April 8, 2022 — Federal officers have made their ultimate determination: Medicare will solely pay for sufferers to get the brand new Alzheimer’s drug aducanumab (Aduhelm) if the sufferers are collaborating in medical trials.
On Thursday, the Facilities for Medicare & Medicaid Companies (CMS) launched its nationwide protection willpower for aducanumab and different related medicine that focus on beta-amyloid within the mind, which is taken into account a trademark of Alzheimer’s illness.
In a press launch, the CMS stated its determination is a two-part coverage based mostly on the presently out there proof for anti-amyloid brokers.
Final yr, the FDA authorized aducanumab for Alzheimer’s illness utilizing the accelerated approval pathway, as a result of trials had proven the drug eliminated beta-amyloid from the mind, however it wasn’t clear the drug had improved the signs of individuals with Alzheimer’s.
The choice sparked controversy and led to the resignation of three members of the FDA’s advisory panel that had voted towards approving the drug.
CMS set far much less restrictive circumstances for potential protection of anti-amyloid medicine which will get full FDA approval sooner or later. In such circumstances, protection can be pegged to participation in CMS-approved research, resembling an information assortment by way of routine medical follow or registries, not solely medical trials.
Howard Fillit, MD, co-founder and Chief Science Officer of the Alzheimer’s Drug Discovery Basis, supported the choice.
“Medicare will now present protection for sufferers enrolled in any FDA- or NIH-approved trial,” Fillit stated. “This is a vital change that may develop entry for extra sufferers to entry the drug in further settings.”
“Though that is an enchancment, it will have been preferable for CMS to incorporate affected person registries, which gather real-world proof that extra intently displays the precise inhabitants residing with Alzheimer’s, in comparison with the restricted populations that enroll in medical trials,” he added. “This method would even have prolonged protection of Aduhelm to extra sufferers presently residing with Alzheimer’s illness.”
He additionally welcomed the flexibleness CMS outlined for future protection of medication with extra compelling knowledge.
“Medication in the identical class will not be essentially equal and every must be evaluated and made out there to sufferers by itself deserves,” Fillit stated.
In a press release, aducanumab producer Biogen disagreed with CMS’ restrict on protection for the drug and protested the two-tiered method created for amyloid-targeting antibody medicine.
“These protection restrictions, together with the excellence between accelerated approval and conventional approval, have by no means been utilized to FDA-approved medicines for different illness areas,” Biogen stated.
Biogen and different critics of the CMS determination contend it denies sufferers entry to a medicine which may gradual Alzheimer’s-related psychological decline, whereas supporters query whether or not exhibiting the drug eliminated beta-amyloid from the mind means it helps sufferers’ signs.
CMS officers stated the company tried to make the method resulting in at present’s determination clear and evidence-based. It famous it gathered greater than 10,000 stakeholder feedback on its draft determination and regarded greater than 250 peer-reviewed paperwork.
“This ultimate Nationwide Protection Willpower displays CMS’ dedication to supply the American public with a clear, trusted, evidence-based determination — with out regard to value — that’s made solely after a radical evaluation of public suggestions,” CMS Administrator Chiquita Brooks-LaSure stated in a press release.
“By means of this determination, we’re making a pathway for folks with Medicare to rapidly entry medicine the FDA determines have proven a medical profit and encourages producers and trial directors to make sure that the medical trials recruit racially various members,” she added.